Cleared Special

K033473 - MODIFICATION TO VORTEX MP VASCULAR ACCE...

K033473 is an FDA 510(k) clearance for MODIFICATION TO VORTEX MP VASCULAR ACCE..., manufactured by Horizon Medical Products, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 15-day FDA review.

K033473 · Horizon Medical Products, Inc. · General Hospital
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Nov 2003
Decision
15d
Days
Class 2
Risk

K033473 is an FDA 510(k) clearance for the MODIFICATION TO VORTEX MP VASCULAR ACCESS PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Horizon Medical Products, Inc. (Manchester, US). The FDA issued a Cleared decision on November 18, 2003 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - the FDA general hospital device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Horizon Medical Products, Inc. devices

FDA 510(k) Submission Details - K033473

510(k) Number K033473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 2003
Decision Date November 18, 2003
Days to Decision 15 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 129d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 126
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K033473.
CELSITE/ CELSITE CONCEPT, ACCESS PORTS
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K031282 · LeMaitre Vascular, Inc. · Aug 2003